Tavalisse, Tavlesse(fostamatinib)
Tavalisse, Tavlesse (fostamatinib) is a small molecule pharmaceutical. Fostamatinib was first approved as Tavalisse on 2018-04-17. It is used to treat thrombocytopenia in the USA. It has been approved in Europe to treat thrombocytopenia.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| hemic and lymphatic diseases | D006425 |
Trade Name
FDA
EMA
Tavalisse
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fostamatinib disodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TAVALISSE | Rigel Pharmaceuticals | N-209299 RX | 2018-04-17 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tavalisse | New Drug Application | 2020-11-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| thrombocytopenia | HP_0001873 | D013921 | D69.6 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
FOSTAMATINIB DISODIUM, TAVALISSE, RIGEL PHARMS INC | |||
| 2025-04-17 | ODE-174 | ||
| 2023-04-17 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Fostamatinib Disodium, Tavalisse, Rigel Pharms Inc | |||
| 8771648 | 2032-07-27 | DP | |
| 8951504 | 2032-07-27 | U-2294 | |
| 8263122 | 2030-11-24 | DP | |
| 8652492 | 2028-11-06 | DP | |
| 7449458 | 2026-09-04 | DP | |
| 8163902 | 2026-06-17 | DP | U-2294 |
| 8445485 | 2026-06-17 | DP | |
| 8912170 | 2026-06-17 | U-2294 | |
| 9283238 | 2026-06-17 | U-2294 | |
| 7989448 | 2026-06-12 | DP | U-2294 |
| 7538108 | 2026-03-28 | DP | U-2294 |
| RE48898 | 2026-01-19 | DP | |
| 8211889 | 2026-01-19 | DP | |
| 9266912 | 2026-01-19 | U-2294 | |
HCPCS
No data
Clinical
Clinical Trials
58 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 7 | 9 | 4 | — | — | 20 |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | 1 | 4 | — | 3 | 8 |
| Covid-19 | D000086382 | U07.1 | 1 | 4 | 3 | — | — | 5 | |
| Hemolytic anemia autoimmune | D000744 | EFO_1001264 | D59.10 | — | 1 | 2 | — | — | 3 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | 1 | 1 | — | — | 2 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 2 | 2 | — | — | 2 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | — | 1 | — | — | 1 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | — | 1 | — | — | 1 |
| Disease | D004194 | EFO_0000408 | R69 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | 2 | — | — | — | 2 | |
| Anemia | D000740 | EFO_0004272 | D64.9 | — | 2 | — | — | — | 2 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | 2 | — | — | — | 2 |
| Coronavirus | D017934 | 1 | 1 | — | — | — | 1 | ||
| Primary myelofibrosis | D055728 | D47.4 | — | 1 | — | — | — | 1 | |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | — | 1 | — | — | — | 1 | |
| Renal cell carcinoma | D002292 | — | 1 | — | — | — | 1 | ||
| Colorectal neoplasms | D015179 | — | 1 | — | — | — | 1 | ||
| Non-small-cell lung carcinoma | D002289 | — | 1 | — | — | — | 1 | ||
| Head and neck neoplasms | D006258 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 7 | — | — | — | — | 7 | ||
| Pharmacokinetics | D010599 | 4 | — | — | — | — | 4 | ||
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | 1 | — | — | — | — | 1 | ||
| Drug interactions | D004347 | 1 | — | — | — | — | 1 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 | ||
| Biological availability | D001682 | 1 | — | — | — | — | 1 | ||
| Myelodysplastic syndromes | D009190 | D46 | 1 | — | — | — | — | 1 | |
| Myelomonocytic leukemia chronic | D015477 | C93.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FOSTAMATINIB |
| INN | fostamatinib |
| Description | Fostamatinib, sold under the brand names Tavalisse and Tavlesse, is a tyrosine kinase inhibitor medication for the treatment of chronic immune thrombocytopenia (ITP). The drug is administered by mouth.
|
| Classification | Small molecule |
| Drug class | phosphoro-derivatives; tyrosine kinase inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COc1cc(Nc2ncc(F)c(Nc3ccc4c(n3)N(COP(=O)(O)O)C(=O)C(C)(C)O4)n2)cc(OC)c1OC |
Identifiers
| PDB | — |
| CAS-ID | 901119-35-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2103830 |
| ChEBI ID | — |
| PubChem CID | 11671467 |
| DrugBank | DB12010 |
| UNII ID | SQ8A3S5101 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Tavalisse - Rigel Pharmaceuticals
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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